dr. Giuseppe Marazzi None conflict of interest

Transcription

1 dr. Giuseppe Marazzi None conflict of interest

2 Are some patients receiving statins unnecessarily? Giuseppe Marazzi, MD, PhD IRCCS San Raffaele, Rome, Italy

3 MRFIT Study: CHD death by level of cholesterol Seven countries study: 25-year CHD mortality rates per baseline cholesterol quartile Arch Intern Med, 1992 JAMA, 1995

4 4S study: Kaplan Meier curve for all-cause mortality Lancet 1994

5 Secondary prevention trial Primary prevention trial

6 Coronary heart disease event rates primary prevention trials secondary prevention trials Low is better JACC 2004

7 Asteroid study: relationship between mean LDL and median change in percent atheroma volume JAMA 2006

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9 Proportional reduction in event rate Proportional reduction in event rate Low is better Reduction in LDL cholesterol (mmol/l) Reduction in LDL cholesterol (mmol/l) Relation between proportional reduction in incidence of major coronary events and major vascular events and mean absolute LDL cholesterol reduction at 1 year Lancet 2005

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11 Studies with statins in special populations Population patients Studio Autore Farmaco ACS MIRACL Schwartz GG, Jama 2001 Atorva 80 Ederly PROSPER Shepherd J, Lancet 2002 Prava 40 hypertension ASCOTT-LLA Sever PS, Lancet 2003 Atorva 10 diabetes CARDS Colhoun HM, Lancet 2004 Atorva 10 Stroke SPARCL Amarenco PN, Engl J Med 2006 Atorva 80 Aortic Stenosis 1873 SEAS Rossebo AB, N Engl J Med 2008 Simva 40 + Ezetimibe PCR > JUPITER Ridker P, N Engl J Med 2008 Rosuva 20

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13 Mortality for all causes Stroke Arch Intern Med 2012

14 JACC 2012

15 Treatment with statins is clearly effective in low-risk patients Statins reduced the risk of serious vascular events of about 21% for every 1 mmol/l reduction in LDL cholesterol in each of the 5 basic categories of risk, including people with the lowest risk of vascular disease as well as the groups with higher risk. Lancet, 2012

16 Secondary prevention is obviously necessary there is a limit to what can be achieved only with the secondary prevention because half of all cardiac deaths occur in people who have already had heart disease. Primary prevention is as well necessary The question is where we set the threshold The meta-analysis data suggest that this should be lowered to a 10% risk in 10 years. The decision to take a statin should be based on risk rather than on the patient's cholesterol level Current guideline recommendations are that if a patient presents a risk of cardiovascular events higher than 20% in 10 years should start a statin. The benefits of statins are still evident for a risk of 10% over 10 years, and even less than that

17 Statin for all over 50 years?

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19 there was an increased risk of myopathy (incidence about 0.05% over 5 years) and rhabdomyolysis (about 0.01% over 5 years) still extremely low in absolute terms. There was also an increase in hemorrhagic stroke... of about 0.5 per 1000 persons treated over 5 years. But this was offset by the reduction of ischemic stroke (as well as the reduction in other vascular occlusive events and death)...there was no evidence that statin therapy increased the risk of developing cancer Lancet, 2010

20 JAMA, 2011

21 Statin and diabetes The risk of developing diabetes with any statin was 1 every 255 patients treated. In low risk patients who have never had heart disease and begin to take statins to lower their risk, the significant reduction of cardio-cerebrovascular risk is important only in 2% of patients. We do not know who are the 2 patients over 100 who will benefit and the 1 over 255 who will become diabetic!

22 Are some patients receiving statins unnecessarily? no except patients without cardiovascular risk factors patients intolerant to statins

23 But how many of those patients who need statins in primary or in secondary prevention do really take them?

24 European and statin Europeans are statin tasters : after 6 months half don t take them anymore!

25 The median time to discontinuation was 3.7 years for secondary prevention and 3.4 years for primary prevention. J GEN INTERN MED 2004

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27 Nutraceuticals for hypercholesterolemia treatment Nutraceutical is a portmanteau of the words nutrition and pharmaceutical, and they are foods or food product sthat provide health and medical benefits Berberine Phytosterols Policosanols Red Yeast Rice

28 Ann Intern Med Nat Med. 2004

29 Changes in lipid profiles after 16 weeks of treatment 248 centers patients ,4 TOT- C LDL -C HDL-C TG ** -19,1 4-10,8-23,5 11,6 * -11,3 * diet diet + nutra ** * p<0,001 vs Diet -17,9 ** p<0,0001 vs Diet

30 A combination of nutraceuticals Improves Insulin Sensitivity in Patients with Metabolic Syndrome: Results of a randomized, double-blind, placebo-controlled trial. G. Carlomagno, F. Affuso, R. Napoli, V. Mercurio, F. Micillo, C. Pirozzi, A. Ruvolo, L.Saccà, S. Fazio Department of Internal Medicine-Federico II University JACC April 5,2011 Volume 57, issue 14 (30)

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32 Thank you for your attention